Federal Register #Docket No. FDA-2018-D-4693

FDA Final Guidance: Postapproval Pregnancy Safety Studies (Informational Notice)

This announcement from the Food and Drug Administration (FDA) provides final guidance to industry on postapproval pregnancy safety studies: - Government Buyer: - Department of Health and Human Services, Food and Drug Administration (FDA) - Purpose and Scope: - Final guidance document titled "Postapproval Pregnancy Safety Studies" released for sponsors and investigators - Offers recommendations for designing studies to assess safety outcomes in pregnant women exposed to FDA-regulated drugs and biological products after approval - Updates and clarifies previous draft guidance, including: - Clarifications on pregnancy registries - Expanded study methods - Updated terminology - Procurement Details: - No products, services, or equipment are being requested or procured - No OEMs or vendors are mentioned - Notable Requirements: - This is an informational notice only; no procurement action is associated - Locations: - FDA headquarters and relevant offices in Rockville and Silver Spring, Maryland

Description

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry titled "Postapproval Pregnancy Safety Studies." This guidance provides recommendations to sponsors and investigators on designing investigations to assess outcomes in pregnant women exposed to drug and biological products regulated by FDA in the postapproval setting. It finalizes the draft guidance issued on May 9, 2019, and includes updates such as clarifications on pregnancy registries, expanded study methods, and updated terminology.

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